Comparison of Two Routes of Administration of a Multimodal Analgesic Protocol in Postoperative Cesarean Section

Centre de Maternité de Monastir

Status and phase: Completed; Phase 3; Phase 2

Conditions: Postoperative Pain; Cesarean Section; Complications, Wound, Infection (Following Delivery); Spinal Anaesthesia During the Puerperium

Treatments: Drug: Nefopam 20 MG/ML; Drug: "Acetaminophen, (paracetamol)" 500Mg Tab; Drug: (Piroxicam "piroxan") 20Mg/1mL Injection; Drug: (Piroxicam "piroxan") 20 MG Oral Tablet; Drug: "Nefopam (Acupan)" 20 MG/ML Injectable Solution; Drug: (Acetaminophen "paracetamol") IV Soln 10 MG/ML

Study type: Interventional

Funder types: Other

Identifiers

NCT03626753

CMNMonastir

Details and patient eligibility

About

Many drugs with various mechanisms of action are used for postcaesarean pain relief. Although the response to pain relief is sometimes believed to be individual, it is very important to establish the most effective with the least adverse effects type of oral analgesia for women after caesarean section. Optimal pain control post-caesarean section will benefit not only the mother and her baby, but also a healthcare system. Optimal pain control may shorten the time spent in hospital after caesarean section and, therefore, reduce healthcare costs.

Full description

Pain after cesarean section (CS), usually described as strong, is an obstacle to good mother-child interaction and post-operative rehabilitation. Its management is important for a quick recovery and allow the mother to take care and link with her newborn. Currently, intrathecal opioids are the most commonly used technique and provide the foundation for post-cesarean analgesia. This technique combined with multimodal analgesia reduces the doses of morphine consumed, including these side effects. Spinal anesthesia is the standard anesthetic technique for caesarean section; it offers several advantages including the possibility of prescribing oral analgesics. An ideal analgesic protocol is one that is simple to implement, cost-effective, and has minimal impact on the work staff. It would have a good safety profile, a low incidence of side effects and complications, and respond to wide inter-patient variability. It relieves the mother of high quality pain while having minimal interference with her, newborn care and anesthesia while allowing safe breastfeeding.

The aim of this work is to compare the quality of an multimodal oral analgesia with intravenous analgesia and to demonstrate non-inferiority of the oral route pain relieve in postoperative caesarean section period. The secondary objectives was to evaluate the maternal tolerance of the drugs (piroxicam, nefopam, paracetamol) used postoperatively of a caesarean section.

Enrollment: 200 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnant in singleton pregnancy with gestational age > 34 weeks
• American society of anesthesiologists (ASA) physical status I-II.

Exclusion criteria

• history of gastrointestinal disorders predisposing to bleeding disorders such as ulcerative colitis,
• Crohn's disease,
• gastrointestinal cancers or diverticulitis,
• an active peptic ulcer,
• an inflammatory gastrointestinal disorder or a gastrointestinal haemorrhage,
• parturients who present preeclampsia,
• premature delivery (<32 weeks),
• constitutional or acquired coagulopathy,
• An antecedent of hemorrhage of the delivery,
• a hemorrhagic complication postoperatively,
• Anemia (hemoglobin less than 8g / 100ml),
• conversion of spinal anesthesia into general anesthesia,
• women with severe medical conditions: renal failure (preoperative creatinine clearance <30ml / min), heart or liver failure.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Oral Group

Active Comparator group

Description:

received in post operative period oral analgesia ( "nefopam (Acupan)" 20mg/6h, "piroxicam (piroxan)" 40mg/24h," Acetaminophen (paracetamol)" 1g/6h)

Treatment:

Drug: (Piroxicam "piroxan") 20 MG Oral Tablet

Drug: "Acetaminophen, (paracetamol)" 500Mg Tab

Drug: Nefopam 20 MG/ML

Intravenous group

Active Comparator group

Description:

received in post operative period intravenous analgesia ( "nefopam (Acupan)" 20mg/6h, "piroxicam (piroxan)" 40mg/24h," Acetaminophen (paracetamol)" 1g/6h)

Treatment:

Drug: (Acetaminophen "paracetamol") IV Soln 10 MG/ML

Drug: "Nefopam (Acupan)" 20 MG/ML Injectable Solution

Drug: (Piroxicam "piroxan") 20Mg/1mL Injection